Improving Mediolateral Walking Balance With an Assistive Exoskeleton
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Partial correlation (rSW) between mediolateral pelvis displacement and step width during unperturbed walking
研究概览
简要总结
Many people who have experienced a stroke have deficits in their walking balance. The long-term goal of this research is to develop an exoskeleton that can effectively improve walking balance, thus improving functional mobility.
详细描述
Walking balance is an important component of functional mobility, with post-stroke balance deficits contributing to a fall rate more than double that of age-matched controls. Unfortunately, traditional therapy approaches have not succeeded in addressing balance deficits or reducing fall risk, motivating the use of technology to fill this gap. Although assistive exoskeletons are a promising approach to improve post-stroke mobility, they have generally not been designed to control walking balance and agility. This limitation is a particular concern in the development of devices for people with stroke, as applying forces to "assist" some aspect of walking (including balance) can have unexpected negative effects. The project goal is to investigate the potential of exoskeleton assistance to improve walking balance that will be accepted by people with stroke. To this end, investigators will use a previously developed hip exoskeleton to quantify the effects of assisting gait stabilization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Evidence of a stroke at least 6 months prior to participation
- •Evidence of dysfunction of the paretic lower limb (Fugl-Meyer lower extremity motor score < 34)
- •At least 21 years of age
- •Self-reported experience of a fall in the previous year, and/or a fear of falling
- •Gait speed of at least 0.2 m/s
- •Ability to walk on a treadmill without a cane or walker
- •Ability to follow three step commands and communicate with experimenters to answer questions (e.g., regarding their balance confidence)
- •Provision of informed consent
排除标准
- •Resting blood pressure higher than 220/110 mm Hg
- •History of unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
- •Preexisting neurological orders or dementia
- •Legal blindness or severe visual impairment
- •Presence of neglect
- •History of DVT or pulmonary embolism within 6 months
- •Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
- •Orthopedic injuries or conditions (e.g., joint replacements) in the lower extremities with the potential to alter the gait pattern
研究组 & 干预措施
xoskeleton Assistance Conditions (No Exoskeleton, Zero, Low, Medium, High Impedance)
Participants in this arm will walk on a treadmill under several conditions. In one condition, they will not wear the exoskeleton. In other conditions, the exoskeleton will be set to zero, low, medium, or high impedance.
干预措施: No Exoskeleton (Device)
xoskeleton Assistance Conditions (No Exoskeleton, Zero, Low, Medium, High Impedance)
Participants in this arm will walk on a treadmill under several conditions. In one condition, they will not wear the exoskeleton. In other conditions, the exoskeleton will be set to zero, low, medium, or high impedance.
干预措施: Exoskeleton (zero impedance) (Device)
xoskeleton Assistance Conditions (No Exoskeleton, Zero, Low, Medium, High Impedance)
Participants in this arm will walk on a treadmill under several conditions. In one condition, they will not wear the exoskeleton. In other conditions, the exoskeleton will be set to zero, low, medium, or high impedance.
干预措施: Exoskeleton (low impedance) (Device)
xoskeleton Assistance Conditions (No Exoskeleton, Zero, Low, Medium, High Impedance)
Participants in this arm will walk on a treadmill under several conditions. In one condition, they will not wear the exoskeleton. In other conditions, the exoskeleton will be set to zero, low, medium, or high impedance.
干预措施: Exoskeleton (medium impedance) (Device)
xoskeleton Assistance Conditions (No Exoskeleton, Zero, Low, Medium, High Impedance)
Participants in this arm will walk on a treadmill under several conditions. In one condition, they will not wear the exoskeleton. In other conditions, the exoskeleton will be set to zero, low, medium, or high impedance.
干预措施: Exoskeleton (high impedance) (Device)
结局指标
主要结局
Partial correlation (rSW) between mediolateral pelvis displacement and step width during unperturbed walking
时间窗: Visit 2, anticipated average 1 week
Mediolateral pelvis displacement will be quantified at the start of each step, and step width will be calculated at the end of each step. Across all steps, the partial correlation between these two metrics will be calculated - accounting for the mediolateral pelvis velocity. This will be done for steps taken with each leg independently.
Partial correlation (rSW) between mediolateral pelvis displacement and step width during speed perturbations
时间窗: Visit 4, anticipated average 1 year
Mediolateral pelvis displacement will be quantified at the start of each step, and step width will be calculated at the end of each step. Across all steps, the partial correlation between these two metrics will be calculated - accounting for the mediolateral pelvis velocity. This will be done for steps taken with each leg independently.
Partial correlation (rSW) between mediolateral pelvis displacement and step width during vision perturbations
时间窗: Visit 4, anticipated average 1 year
Mediolateral pelvis displacement will be quantified at the start of each step, and step width will be calculated at the end of each step. Across all steps, the partial correlation between these two metrics will be calculated - accounting for the mediolateral pelvis velocity. This will be done for steps taken with each leg independently.
Partial correlation (rSW) between mediolateral pelvis displacement and step width during mediolateral pull perturbations
时间窗: Visit 4, anticipated average 1 year
Mediolateral pelvis displacement will be quantified at the start of each step, and step width will be calculated at the end of each step. Across all steps, the partial correlation between these two metrics will be calculated - accounting for the mediolateral pelvis velocity. This will be done for steps taken with each leg independently.
次要结局
- Partial correlation between mediolateral pelvis displacement and mediolateral foot placement (unperturbed walking)(Visit 2, anticipated average 1 week)
- Average gluteus medius activity during stance phase (surface EMG) in unperturbed walking(Visit 2, anticipated average 1 week)
- Average gluteus medius activity during swing phase (surface EMG) in unperturbed walking(Visit 2, anticipated average 1 week)
- Rating of Perceived Stability (RPS) during unperturbed walking(Visit 2, anticipated average 1 week)
- Partial correlation between mediolateral pelvis displacement and mediolateral foot placement during speed perturbations(Visit 4, anticipated average 1 year)
- Average gluteus medius activity during stance phase (surface EMG) with speed perturbations(Visit 4, anticipated average 1 year)
- Average gluteus medius activity during swing phase (surface EMG) with speed perturbations(Visit 4, anticipated average 1 year)
- Rating of Perceived Stability (RPS) with speed perturbations(Visit 4, anticipated average 1 year)
- Partial correlation between mediolateral pelvis displacement and mediolateral foot placement during vision perturbations(Visit 4, anticipated average 1 year)
- Average gluteus medius activity during stance phase (surface EMG) with vision perturbations(Visit 4, anticipated average 1 year)
- Average gluteus medius activity during swing phase (surface EMG) with vision perturbations(Visit 4, anticipated average 1 year)
- Rating of Perceived Stability (RPS) with vision perturbations(Visit 4, anticipated average 1 year)
- Partial correlation between mediolateral pelvis displacement and mediolateral foot placement during mediolateral pull perturbations(Visit 4, anticipated average 1 year)
- Average gluteus medius activity during stance phase (surface EMG) with mediolateral pull perturbations(Visit 4, anticipated average 1 year)
- Average gluteus medius activity during swing phase (surface EMG) with mediolateral pull perturbations(Visit 4, anticipated average 1 year)
- Rating of Perceived Stability (RPS) with mediolateral pull perturbations(Visit 4, anticipated average 1 year)
- Change in mediolateral foot placement (cm) during pull perturbations relative to unperturbed steps(Visit 4, anticipated average 1 year)
研究者
Jesse Dean
Professor-Faculty
Medical University of South Carolina